MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-25 for FREESTYLE LIBRE 14 DAY 71938-01 manufactured by Abbott Diabetes Care Inc.
[185904579]
The product has been requested back for an investigation. A follow-up report will be submitted once additional information is obtained. The exact date that the incident occurred is unknown. The date entered is based on the customer report of "last week". All pertinent information available to abbott diabetes care has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[185904580]
On (b)(6) 2020, customer had initially reported the adc freestyle libre reader not powering on with button press or test strip insertion. On (b)(6) 2020, customer reported that due to a delivery issue involving the replacement reader, customer was unable to test and therefore experienced a medical event. Customer reportedly experienced unspecified symptoms of "low glucose" and visited his doctor for an appointment he had a week before the call. Customer reportedly received unspecified dose of insulin lantus by the doctor to "raise his glucose levels". There was no report of death or permanent injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954323-2020-02313 |
| MDR Report Key | 9881147 |
| Report Source | CONSUMER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2018-12-20 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TARA WILLIAMSON |
| Manufacturer Street | 1360 SOUTH LOOP ROAD |
| Manufacturer City | ALAMEDA CA 945027001 |
| Manufacturer Country | US |
| Manufacturer Postal | 945027001 |
| Manufacturer Phone | 5108644472 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREESTYLE LIBRE 14 DAY |
| Generic Name | FLASH GLUCOSE MONITORING SYSTEM |
| Product Code | PZE |
| Date Received | 2020-03-25 |
| Model Number | 71938-01 |
| Catalog Number | 71938-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETES CARE INC |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 945027001 US 945027001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |